RecruitingPhase 3NCT05956639

Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in mHSPC

A Multi-center, Randomized, Open-label Clinical Trial Comparing a 6-month vs Long-term Course of Rezvilutamide With ADT Plus Chemotherapy in High Tumor Burden mHSPC

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

100 participants

Start Date

Jun 20, 2023

Study Type

INTERVENTIONAL

Conditions

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Summary

Primary Objective: To explore whether a 6-month course of Rezvilutamide in the triple therapy regimen is non-inferior to long-term Rezvilutamide treatment in improving radiographic progression-free survival (rPFS) in patients with high tumor burden metastatic hormone-sensitive prostate cancer (mHSPC). Secondary Objectives: To evaluate and compare the time to prostate-specific antigen (PSA) progression, time to next bone-related event, time to initiation of subsequent anti-prostate cancer treatment, and objective response rate (ORR) between the 6-month and long-term course of Rezvilutamide with androgen deprivation therapy (ADT) plus docetaxel in patients with high tumor burden mHSPC. To assess and compare the incidence of adverse events between the 6-month and long-term course of Rezvilutamide with ADT plus docetaxel in patients with high tumor burden mHSPC. Exploratory Objectives: To observe the circulating tumor cell status at 6 months, 12 months, 18 months, and 24 months in patients with high tumor burden mHSPC receiving the triple therapy regimen.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment lengths for men with newly diagnosed high-volume metastatic prostate cancer: a 6-month course of the androgen-blocking drug rezvilutamide combined with hormone therapy and chemotherapy, versus a long-term (ongoing) course of the same combination. **You may be eligible if...** - You are a male aged 18 or older with confirmed metastatic prostate cancer with high tumor burden (4+ bone metastases or organ metastases) - You are planned for or already receiving hormone therapy (ADT) plus 6 cycles of docetaxel chemotherapy - Your organ function (blood counts, liver, kidney, heart) meets required levels **You may NOT be eligible if...** - You have previously received extensive treatment for prostate cancer (exceptions apply for short-term hormone therapy) - You have brain metastases - You have had a seizure or stroke-like event in the past 12 months - You have significant heart disease in the past 6 months - You have active HIV, hepatitis B, or hepatitis C - You have a history of organ transplant or immune deficiency Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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